NCT01266239

Brief Summary

In study-1, the purpose of this study is to compare the long-term outcome of provisional stenting between EES and SES deployment. In study-2, it is to prove the following hypothesis " Asymmetrical expansion in the bifurcation lesion leads to frequent inhomogeneous intimal growth on the strut and thrombus attachment."

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 24, 2010

Status Verified

December 1, 2010

Enrollment Period

2 years

First QC Date

December 22, 2010

Last Update Submit

December 23, 2010

Conditions

Ischemic Heart Disease

Keywords

Bifurcation lesion, drug-eluting stent, symmetric expansion

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    Cardiac death, myocardila infarction, target lesion revascularization, target vessel revascularization, and stent thrombosis are monitored.

    3 years

Secondary Outcomes (1)

  • abnormal intimal coverage

    9 months

Study Arms (4)

SES-KB

ACTIVE COMPARATOR

Sirolimus-eluting stent (SES) is deployed in the main vessel (MV)and subsequent kissing balloon inflation is performed in the bifurcation.

Procedure: kissing balloon inflationDevice: EES vs. SES

SES-NK

ACTIVE COMPARATOR

SES is deployed in the MV without kissing balloon inflation.

Procedure: kissing balloon inflationDevice: EES vs. SES

EES-KB

ACTIVE COMPARATOR

Everolimus-eluting stent (EES) is deployed in the MV and subsequent kissing balloon inflation is performed in the bifurcation.

Procedure: kissing balloon inflationDevice: EES vs. SES

EES-NK

ACTIVE COMPARATOR

EES is deployed in the MV without kissing balloon inflation.

Procedure: kissing balloon inflationDevice: EES vs. SES

Interventions

kissing balloon inflationPROCEDURE

Kissing balloon inflation following the MV stenting

EES-KBEES-NKSES-KBSES-NK
EES vs. SESDEVICE

Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.

EES-KBEES-NKSES-KBSES-NK

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary bifurcation lesion which stenotic lesion exists in the MV and / or in the side branch (SB).
  • The lesion is appropriate for the provisional MV stenting.
  • The reference diameter is more than 2.5mm in the MV and more than 2.0mm in the SB.

You may not qualify if:

  • Left main coronary bifurcation
  • Acute myocardial infarction and unstable angina which culprit vessel contains obvious thrombus
  • Left ventricular ejection fraction \< 30%
  • Shock state
  • Inappropriate candidate for the dual antiplatelet therapy, administration of contrast medium and radiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Kobe University

Kobe, Japan

RECRUITING

Hyogo Medical University

Nishinomiya, Japan

RECRUITING

Toyohashi Heart Center

Toyohashi, Japan

RECRUITING

Saiseikai Yokohama Eastern Hospital

Yokohama, Japan

RECRUITING

New Yukuhashi hospital

Yukuhashi, 824-0026, Japan

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Yoshinobu Murasato, MD, PhD

    New Yukuhashi Hospital

    PRINCIPAL INVESTIGATOR

  • Yoshihisa Kinoshita, MD

    Toyohashi Heart Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoshinobu Murasato, MD, PhD

CONTACT

+81-930-24-8899murasato@shinyukuhashihospital.or.jp

Yoshihisa Kinoshita, MD

CONTACT

+81-532-37-3377Ykinoshita@heart-center.or.jp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

December 22, 2010

First Posted

December 24, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2015

Last Updated

December 24, 2010

Record last verified: 2010-12

Locations

JP(5)